Precision, cost-effectiveness, and efficiency are critical in the fast-paced world of clinical trials. Sponsors and suppliers are under more pressure than ever to make sure that investigational items and supplies are delivered on time, without needless waste or delays, as clinical trials spread around the world. The management of clinical trial supplies is being revolutionized by the this system in production and delivery approach. This system aims to address the cost and efficiency issues of keeping ancillary supplies, patient kits, and investigational medicinal products on hand in clinical trials, ensuring timely access to patient demand.
Because the automaker Toyota implemented just-in-time production in the 1970s, it is often referred to as the Toyota Production System (TPS).
Furthermore, World BI arrange conferences in field of Clinical Trial Supply Forum, discuss the importance and role of this system in Clinical Trial Supply and signify the future trends and development of this system in Clinical Supply Chain.
Emergence in Clinical Trials:
- In 2021, the UK government suggested modifying the law to speed up clinical studies and provide life-altering medications more quickly.
- Faster research and shorter turnaround times for clinical trial approvals were suggested by an independent assessment in 2023.
- With a focus on clinical trials, the Medicines Manufacturing Innovation Center's Grand Challenge 2 seeks to integrate this system into the pharmaceutical manufacturing process by lowering barriers, expenses, and waste.
Role:
1. Demand Driven Production:
- By leveraging real-time data from trial sites to create just the necessary amounts, this manufacturing reduces the danger of excess stock becoming outdated or expiring and matches clinical supplies with patient enrollment and site needs.
2. On-Demand Distribution:
- This reduces storage times at distribution centers and clinical sites by shipping clinical supplies as needed.
- This method gives clinical trials the flexibility they need by enabling faster adaptations to modifications in patient numbers, site activations, or protocol revisions.
3. Reduced Waste:
- This system considerably lowers the chance of overproduction by producing and distributing goods in more accurate, smaller amounts.
- Clinical goods, particularly medications, sometimes have short shelf lives, and it is expensive and ineffective to waste materials that are out-of-date or superfluous.
- Because of this system produces supplies closer to the point of demand, waste is reduced.
4. Quicker Reaction to Changes:
- Unexpected modifications, such as shifts in patient recruitment, protocol modifications, or trial extensions, are frequent in clinical trials.
- By enabling sponsors to adjust production and distribution levels in response to real-time trial results in increased agility.
- This is especially helpful for studies that have staggered enrollments or are adaptive.
5. Cost Efficiency:
- Keeping more inventory results in increased expenses for transportation, warehousing, and refrigeration (for medications that are sensitive to temperature changes).
- By simply manufacturing what is required, when required this system lowers these expenses.
- Additionally, this lessens the study's overall logistical impact, especially for international trials with several trial locations spread across various geographical areas.
Principal Advantages in Clinical Trials
Inventory Optimization:
This system minimizes the expense of keeping extra stock on hand and prevents shortages that can cause trials to be delayed by ensuring that clinical locations receive the proper quantity of supplies.
Improved Patient Safety:
(JIT) manufacturing enables stricter batch tracking and quality control, which is essential for maintaining patient safety and regulatory compliance.
Regulatory Compliance:
This system assists sponsors with fulfilling Good Manufacturing Practice (GMP) standards and other strict regulatory criteria for clinical trials. It lowers the possibility of compliance problems by guaranteeing the traceability and documentation of every product batch.
Sustainability:
By reducing the environmental effect of overproduction, storage, and transportation, waste reduction and supply chain optimization also help achieve sustainability goals.
Kanban-Conjucate with JIT:
Kanban a Japanese scheduling method developed by Toyota engineer Taiichi Ohno, is commonly used in this system and lean production to enhance production efficiency by tracking lead and cycle times, identifying trouble spots, and determining inventory limits.
Risk and Challenges:
Delay in Site Activation:
- When suitable individuals are identified, site activation may be delayed if sites are not sufficiently prepared beforehand.
- This could prolong trial durations and slow down patient recruitment.
Increasing Workload at Sites:
- This system may result in an increased operational strain on research sites, which might cause quality problems or site fatigue.
Concerns About Regulation and Compliance:
- Because of this system trials move quickly, there is a chance that sites will occasionally violate ethical or regulatory requirements, particularly when they are activated on short notice.
Challenges in Logistics:
- It might be logistically difficult to coordinate infrastructure, personnel, and supplies at short notice, which could cause delays or mistakes in trial conduct.
Monitoring and Data Quality:
- Quick activation might occasionally deteriorate the quality of the data or make it challenging to keep up steady monitoring across several locations.
Uncertainty in Finances:
- The clinical trial budgeting in this sysstem might be complicated and result in cost inefficiencies as patient recruitment and site activations may be more erratic.
Supply Chain Disruptions:
- Trial schedules may be impacted by any manufacturing or delivery delays.
- Therefore, to reduce risks like production problems, transportation interruptions, or delays in procuring raw materials, a strong contingency plan is important.
Technology Integration:
- Cutting-edge technological platforms that combine clinical trial management systems and supply chain data are necessary for its implementation.
- For making it to be successful, precise forecasting, real-time inventory management, and patient registration data are essential.
Consideration:
- The strategy in clinical trials involves site readiness, patient identification, logistical planning, regulatory compliance, data management, and financial flexibility.
- It ensures quick site activation, uses pre-negotiated contracts and permits, and uses predictive analytics for participant identification.
- It also ensures timely deployment of personnel, equipment, and infrastructure, ensuring compliance with regulations and maintaining integrity in data management.
Future Trends:
- he demand for this system in supply chain solutions in clinical trials is expected to rise due to decentralized trial designs, tailored medication, and globalization. Advancements in data analytics, AI-driven forecasting, and digital supply chain management will simplify the application of JIT strategies, ensuring smooth, quick, and affordable clinical trials.
- It helps reduce waste, cut costs, and improve trial efficiency by coordinating production and delivery with real-time demand.
Clinical Trial Supply Forum:
The significance of JIT in clinical trials will be discussed at our Clinical Trial Supply Forum, World BI conferences. Raising the awareness of importance of this method in speeding up clinical trials is the goal of this topic. We'll talk about how this system works well for clinical trials' production and distribution processes as well as what cost-cutting measures we should use. In order to expedite the clinical trials, participants will have the opportunity to explore this system, engage in debates, and share their ideas and experiences.